Study of ONO-1101 in Patients Scheduled for Coronary Angiography

NCT ID: NCT00560209

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

P

Group Type PLACEBO_COMPARATOR

ONO-1101

Intervention Type DRUG

placebo for 1 minute IV

E2

Group Type EXPERIMENTAL

ONO-1101

Intervention Type DRUG

0.125 mg/kg for 1 minute IV

E1

Group Type EXPERIMENTAL

ONO-1101

Intervention Type DRUG

0.06 mg/kg for 1 minute IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ONO-1101

placebo for 1 minute IV

Intervention Type DRUG

ONO-1101

0.06 mg/kg for 1 minute IV

Intervention Type DRUG

ONO-1101

0.125 mg/kg for 1 minute IV

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 20 years of age or older
* Heart rate less than 90 beats/min and more than 70 beats/min at entering the CT room

Exclusion Criteria

* Previous allergic reactions to contrast agent
* Renal failure
* Asthma
* Concomitant beta-receptor blocking agent
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shinichi Kikawa

Role: STUDY_DIRECTOR

Ono Pharmaceutial Co., Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kinki Region

Kinki, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

Jinzaki M, Hirano M, Hara K, Suzuki T, Yamashina A, Ikari Y, Iino M, Yamaguchi T, Kuribayashi S. A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting beta1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease. Int J Cardiovasc Imaging. 2013 Jun;29 Suppl 1(Suppl 1):7-20. doi: 10.1007/s10554-013-0253-3. Epub 2013 Jun 20.

Reference Type DERIVED
PMID: 23784548 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ONO-1101-26

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of DU-176b Aged 80 Years or Older
NCT02801669 COMPLETED PHASE3
Early Aortic Valve Lipoprotein(a) Lowering Trial
NCT02109614 WITHDRAWN EARLY_PHASE1